NCT07361055

Brief Summary

Primary Objective: To observe, record, and analyze the workflow and guidance system efficiency of these two surgical procedures, including placement time, location, and the number of successful placements. Secondary Objective: To compare the differences between the two procedures and observe and record the process of transitioning to intracardiac ultrasound guidance by experienced physicians performing both workflows. The primary focus is on the time spent on target steps and related complications, with the aim of reducing radiation exposure during the procedure with the new technology.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Mar 2025Dec 2027

Study Start

First participant enrolled

March 26, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 22, 2026

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

CryoablationCardio Vascular Disease

Keywords

zero-fluoroscopyparoxysmal supraventricular tachycardia ablation

Outcome Measures

Primary Outcomes (1)

  • The success of ablation

    defined by elimination of accessory pathway and slow nodal pathway or modification of the slow nodal pathway with which a PSVT upto 3 reentrants would not be induced

    1Year

Secondary Outcomes (1)

  • The complication rates

    1Year

Study Arms (2)

Protocol A (Fam DX+)

EXPERIMENTAL

Create geometry FAM Mapping with DECANAV(Fam DX+)

Device: Protocol A

Protocol B (FAM DX-)

ACTIVE COMPARATOR

Create geometry FAM MAPPING WITH NAVISTAR (FAM DX-)

Device: Protocol B

Interventions

Protocol BDEVICE

Mapping with NAVISTAR

Also known as: FAM DX-, NAVISTAR®
Protocol B (FAM DX-)
Protocol ADEVICE

Mapping with DECANAV

Also known as: FAM DX+, DECANAV®
Protocol A (Fam DX+)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with documented PSVT on ECG. Twelve-lead is preferred. Single-lead is acceptable if recording quality is good enough for interpretation.
  • Patients who are willing to sign the informed consent.

You may not qualify if:

  • The patients had received PSVT ablation procedure before.
  • Informed consent could not be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospita

Taipei, 100, Taiwan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 22, 2026

Study Start

March 26, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 22, 2026

Record last verified: 2025-03

Locations

TW(1)